Phase 1
N=40
Feasibility of Aromatherapy in an Awake Craniotomy Environment
Intracranial Pathology
Bottom Line
View on ClinicalTrials.gov: NCT03328143 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Consented Patients — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lavender (Lavandula angustifolia) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Consented Patients |
40 | — |
| PRIMARY Protocol Completion |
31 | — |
| SECONDARY Validation of Visual Analogue Scale for Anxiety (VAS-A) |
3.1 | — |
| SECONDARY Validation of Visual Analogue Scale for Pain (VAS-P) |
1.1 | — |
| SECONDARY Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. |
0; 1; 5; 12; 13 | — |
Summary
Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Though many patients tolerate awake cranial surgery well, recent studies found that roughly 30% of patients experience moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the satisfaction with pain control.
Eligibility Criteria
Inclusion Criteria
- Any adult patient aged 18 and older undergoing awake cranial neurosurgery
Exclusion Criteria
- Allergy or sensitivity to the aromatherapy agent (Lavender)
- Aversion to lavender scent
- History of asthma, chronic obstructive pulmonary disease (COPD)
- History of contact dermatitis following exposure to cosmetic fragrances
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03328143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.